Avitears
- Product NDC
- 49869-002
- 11-digit product format
- 498690002
- Labeler code
- 49869
- Product ID
- 49869-002_a238b922-010a-40fb-8ee8-da3a82c376c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- polysorbate 80
- Dosage form
- SOLUTION/ DROPS
- Route
- TOPICAL
- Labeler
- Pinnacle Science, LLc
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2009-07-17
- Marketing end
- 0000-00-00
- Substance
- POLYSORBATE 80
- Active strength
- 10 mg/mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49869-002-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cb55-621f-e053-dbdaa90a74ad | Avitears Lubricating Eye Drops |
| 49869-002-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cb55-621f-e053-dbdaa90a74ad | Avitears Lubricating Eye Drops |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49869-002-01 | Avitears | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 15 | 1 | |
| 49869-002-02 | Avitears | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 10 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| polysorbate 80 | ACTIVE INGREDIENT | 6OZP39ZG8H | AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] | 1 | |
| polysorbate 80 | ACTIVE MOIETY | 6OZP39ZG8H | AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] | 1 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] | 1 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1039277 | Avitears 1 % Ophthalmic Solution | PSN | dbb0d312-c79a-4c89-acb1-b895b52c05d5 | 1 |
| 998224 | polysorbate 80 1 % Ophthalmic Solution | PSN | dbb0d312-c79a-4c89-acb1-b895b52c05d5 | 1 |
| 1039277 | polysorbate 80 10 MG/ML Ophthalmic Solution [Avitears] | SBD | dbb0d312-c79a-4c89-acb1-b895b52c05d5 | 1 |
| 998224 | polysorbate 80 10 MG/ML Ophthalmic Solution | SCD | dbb0d312-c79a-4c89-acb1-b895b52c05d5 | 1 |
| 1039277 | Avitears 1 % Ophthalmic Solution | SY | dbb0d312-c79a-4c89-acb1-b895b52c05d5 | 1 |
| 1039277 | Avitears 10 MG/ML Ophthalmic Solution | SY | dbb0d312-c79a-4c89-acb1-b895b52c05d5 | 1 |
| 998224 | polysorbate 80 1 % Ophthalmic Solution | SY | dbb0d312-c79a-4c89-acb1-b895b52c05d5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 49869-002-01 | 49869000201 | 15 mL in 1 BOTTLE, PLASTIC | 15 ml | Historical |
| 49869-002-02 | 49869000202 | 10 mL in 1 BOTTLE, PLASTIC | 10 ml | Historical |